MAUDE Adverse Event Report: CONMED CORPORATION VCARE UTERINE MANIPULATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number MEDIUM

Device Problems Break (1069); Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

While attempting to remove the uterus from the patient using the vcare uterine manipulator, the device came apart leaving pieces of the device inside the patient.Two cups came off and were retrieved under direct visualization of the laparoscope via vagina.All pieces were removed from the patient as well as the specimen.All pieces were evaluated and matched by staff.

• Brand Name: VCARE UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 6084947
• MDR Text Key: 59361058
• Report Number: 6084947
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/08/2018
• Device Model Number: MEDIUM
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201608081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 39 YR